Kornimate/medical-research-clean huggingface dataset:
efficacy of triclosan-coated sutures in the episiotomy

Conditions: Episiotomy

Summary: surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. the aim of this study was to compare the surgical site infection with triclosan-coated suture (vicryl plus) versus coated suture (vicryl) in the episiotomy after delivery.

women undergoing planned were randomized to either episiotomy suture with vicryl plus or vicryl. the primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (ssi) or wound disruption one week after episiotomy. secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication). data were analyzed according to the intention to treat principle.

Eligibility criteria:
inclusion criteria: * pregnant women who had had an episiotomy at the delivery * vaginal delivery * no further perineal or vaginal lesions present exclusion criteria: * collagen disease * known immunodeficiency * clinical signs of infection at the time of episiotomy * history of keloids and a medical disorder that could affect wound healing * hypersensitivity to any of the suture materials used in the protocol * diabetes mellitus * disorders requiring chronic corticosteroid use or immunosuppression * instrumental extraction

Keywords: triclosan sutures infection
cerebral and autonomic responses to pain in healthy humans

Conditions: Nociceptive Pain; Anesthesia; Healthy

Summary: evaluating the intraoperative pain is a major challenge for the anesthesia team. during anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. the new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (surgical pleth index (spi index)), the pupil dilation reflex, respiratory sinus arrhythmia (ani, analgesia nociception index), or skin conductance index. taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values. however, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. this constitutes a limit of the practitioners' confidence in these monitoring tools. the nociception transmission pathways of to the vegetative centers and cortical areas are complex. investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. in this project investigators investigate the relation between cortical (eeg) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.


Eligibility criteria:
inclusion criteria: * healthy volunteer over 18 years old * signed informed consent * affiliated to a social security exclusion criteria: * chronic pathology requiring chronic treatment * cardiac rhythm disorders, pacemaker, cardiotropic treatment * taking opioid analgesics during the previous week * painful chronic, or migraine * pathology of the hand, acrosyndrome, carpal tunnel syndrome * pregnancy * people placed under protection of justice

Keywords: nociceptive stimulation healthy volunteer simultaneous cortical activation neuro-vegetative response
improving outcome of selected patients with non-resectable hepatic metastases from colo-rectal cancer with liver transplantation

Conditions: Liver Metastases; Colorectal Cancer Metastatic; Liver Neoplasm; Neoplasms

Summary: the colt trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: os) of liver transplantation (lt) in liver-only crc metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase iii italian rct on triplet chemotherapy+antiegfr


Eligibility criteria:
inclusion criteria: * histologically confirmed non-mucinous colon adenocarcinoma. * primary tumor as pt1-3, pn0 or pn1 (metastases in \< 4 regional lymph nodes), confirmed r0 resection. * ras and braf wild-type \& mss molecular status as per local testing. * liver metastases not eligible for curative liver resection * objective response according to recist 1.1 to first-line treatment, with sustained response for at least 4 months, or disease control (cr+pr+sd) during second-line treatment for at least 4 months. * a maximum of two prior chemotherapy treatment lines. * performance status, ecog 0. * satisfactory blood tests hb \>10g/dl, neutrophils \>1.0 (after any g-csf), trc \>75, bilirubin\<2 x upper normal level, ast, alt\<5 x upper normal level, creatinine \<1.25 x upper normal level. * cea\<50 ng/ml exclusion criteria: * hereditary crc syndromes including fap and lynch syndrome. * prior extra hepatic metastatic disease or primary tumor local relapse. * extra-peritoneal cancers (rectum). * other malignancies in the previous 5 years * active intra-venous or alcohol abusers * hiv infection

Keywords: liver transplant colorectal cancer chemotherapy metastasis
the effect of single umbilical artery caused by umbilical artery embolism on pregnancy outcome

Conditions: Umbilical Artery Embolism,Single Umbilical Artery,Pregnancy Outcome

Summary: to investigate the relationship between single umbilical artery caused by umbilical artery embolism and pregnancy outcome , and to provide evidence-based evidence for peripartum health care of pregnant women with umbilical artery embolism.


Eligibility criteria:
inclusion criteria: * age 18 \~ 34years old * b-ultrasound first showed double umbilical artery, then single umbilical artery or pregnant women with umbilical artery embolism supported by intrapartum and postpartum pathology. * b-ultrasound of prenatal examination showed a single umbilical artery, and prenatal and postpartum pathology showed pregnant women with a single umbilical artery. exclusion criteria: * the fetus has extracardiac malformation and aneuploid deformity
the effect of scent on pregnancy induced nausea, vomiting, and quality of life

Conditions: Morning Sickness; Pregnancy Early

Summary: this study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.

the inhalation of certain essential oils has been found to reduce feelings of nausea and to improve quality of life during pregnancy. the essential oils used in this study are applied topically to the temples and jaw line every 4-6 waking hours over a 6-day period. each application will produce an exposure that lasts up to 30-45 minutes before fading. at the end of each day, nausea and vomiting levels will be assessed using a validated measurement instrument. quality of life is measured using a 30-question tool that measures both pregnancy-related quality of life and pregnancy-induced nausea and vomiting.

Eligibility criteria:
inclusion criteria: * age: 18-45 years * confirmed pregnancy * healthy pregnancy exclusion criteria: * hyperemesis gravidarum * tobacco use in the home * high risk pregnancy

Keywords: aromatherapy essential oils
is cerazette use before nexplanon insertion predictive for bleeding pattern?

Conditions: Bleeding

Summary: the purpose of the study is to examine how well three months preceding use of cerazette progestin only pill predicts the bleeding pattern during following nexplanon implant use.


Eligibility criteria:
inclusion criteria: * healthy women, 18-40 years of age * regular menstrual cycle (period 23-35 days) exclusion criteria: * -immediate previous use of progestin only contraception within 2 months * known or suspected pregnancy * acute tromboembolic disorder * presence or history of hepatic disease, as long as the liver function values have not returned to normal * undiagnosed vaginal bleeding * known or suspected sex-steroid influenced malignancies (e.g. breast cancer) * hypersensitivity to the active substances or to any of the excipients of the medicines * pregnant or breast feeding within 6 weeks * the use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome p450). examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing st.john's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.

Keywords: focus: preceding desogestrel predicts pattern of following etonogestrel implant
photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis - phase 2 clinical trial

Conditions: Actinic Cheilitis; Leukoplakia; Erythroplakia

Summary: brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. many europeans migrated to brazil escaping either war or economic crisis to live in the country searching for opportunities. low phototype combined with high incidence of uv light is a combination that not only affect the skin but also the lips. the current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with histopathological confirmation of actinic cheilitis * patients will be requested to respect the timeframe of clinical consultations * no treatment for actinic cheilitis in the last 3 months exclusion criteria: * histopathological diagnosis of squamous cell carcinoma (scc) * patient presenting any type of immunosupression * recurrent crust of the lip vermilion (high risk of scc)

Keywords: pdt actinic cheilitis phase 2 clinical trial
assessment of muscle function and size in older adults with rotator cuff tear

Conditions: Rotator Cuff Tear

Summary: adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. the goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. this pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. the investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. the investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. this study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the pepper center.


Eligibility criteria:
inclusion criteria: * adults ≥ 60 years of age * free of any medical condition that might be exacerbated by physical testing * patients: major thickness supraspinatus tear * control subjects: no history of significant injury or pathology in either upper limb exclusion criteria: * contraindication to undergoing mri * history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, parkinson's, or spinal cord injury, or being confined to a wheelchair)

Keywords: aging
performance evaluation by the user of bgm contour care according to iso 15197:2015

Conditions: Diabetes

Summary: performance evaluation by the user of the blood glucose monitoring systemcontour care in accordance with din en iso 15197:2015


Eligibility criteria:
inclusion criteria: * male or female patients with clinical indication for blood glucose measurements (i.e. diabetes mellitus) * male or female patients with hypo-, eu- or hyperglycemia * the written informed consent had to be signed * the volunteers must be older than 18 years * the volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved exclusion criteria: * pregnancy or lactation * acute or chronic diseases that * pose a risk of aggravation by the measure * pose a health hazard to the personnel * a current constitution that does not allow participating in the study * participation in another study or activity with the blood glucose measuring system evaluated in the present study * application of substances listed in appendix a of din en iso 15197:2015
cilostazol for hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: determine if cilostazol improves symptoms and ntprobnp levels (heart failure blood marker) in heart failure with preserved ejection fraction (hfpef) - a prevalent syndrome without targeted evidence-based treatment. this will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1 study design with placebo and cilostazol

heart failure (hf) is the #1 reason for hospital admissions. about half of the patients with hf have a preserved ejection fraction (hfpef). there is no targeted evidence-based treatment for hfpef. we recently reported that elevating the heart rate with pacemakers conveys clinical benefits e.g. reduction in heart failure symptoms, lowering filling pressures and an increase in walk distance. cilostazol is a pde3 inhibitor that increases the heart rate by about 5-8 beats per minute and has other potentially beneficial hfpef effects such as peripheral vasodilation, lusitropic effects and dromotropic effects. by activating proteinkinase a, cilostazol may also phosphorylate titin, which may reduce myocardial stiffness. n-of-1 study design using the standard dose cilostazol formulation of 100mg twice a day approved for peripheral vascular disease. the investigators and patients are blinded. the patients serve as their own controls with two crossovers (week 1: cilostazol or placebo - week 2: placebo or cilostazol - week 3: cilostazol or placebo - week 4: placebo or cilostazol).

Eligibility criteria:
inclusion criteria: * \>18 yrs * lvef ≥ 50% (on last assessment, \<2 years) * diagnosis of hfpef or shortness of breath with nyha class ≥ 2 and one of the following: 1. pulmonary edema on chest imaging or documented on exam or on loop diuretics 2. ntprobnp \>400 ng/ml in the last 24 months 3. hfpef\>50% hospitalization in the last 3 years 4. qualitative echo: \> mild diastolic dysfunction on echo report and \> mild left ventricular hypertrophy and left atrial dilation or quantitative echo: left ventricular hypertrophy \[men ≥115 g/m², women ≥95 g/m² or relative wall thickness \>0.42 or any lv wall thickness \>1.2cm and has la dilation (\>28ml/m2) exclusion criteria: * \<18yo * resting heart rate \>100/min * patients with lvef \<50% * advanced end-stage heart failure, * symptomatic copd on home o2, * uncontrolled severe htn (sbp \>160/100 mmhg) * patients with life expectancy \<6 months, * end-stage liver cirrhosis, * more than moderate valve disease, * infiltrative myocardial disease * constrictive pericarditis or myocarditis, * patients unable to participate in follow up, * pregnant patients or patients without reliable contraceptive agent for the duration of study participation), * left ventricular outflow tract obstruction, * bleeding dyscrasias, blood dyscrasias, * patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine, fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
safety and efficacy study of human esc-derived neural precursor cells in the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: this study will evaluate the safety and efficacy of intracerebral transplantation of human embryonic stem cells-derived neural precursor cells in patients with parkinson's disease.

this study is a phase i/ii, open-label, non randomized clinical trial. the study will enroll 50 patients for cell injection, administering a single dose of neural precursor cells by stereotaxic intra-striatal injection.

Eligibility criteria:
inclusion criteria: 1. primary parkinson's disease patients，a history over 5 years，females or males; 2. cannot effectively control the pd or tolerate the side effects of drugs; 3. hoehn and yahr stage 3 or 4 in the off state at screening 4. age between 50 and 80 years; 5. dopamine is effective or once; 6. sign the informed consent exclusion criteria: 1. atypical parkinsonian syndrome or only having tremor syndrome; 2. having been done pallidotomy, dbs, striatum or extrapyramidal surgery; 3. subjects are using apomorphine or anticoagulant; 4. subjects used immunosuppressant or antipsychotic drugs in last 3 months; 5. subjects used botulinum toxin, phenol, or other drugs for the treatment of dystonia or muscle cramps in last 6 months; 6. during the period of active epilepsy preventing epilepsy with antiepileptic; 7. coagulant function abnormality or other obviously abnormal laboratory test results; 8. having skin basal cell carcinoma or cervical cancer and other pre-cancerous lesions; 9. subject has a history of chronic alcohol or drug abuse ; 10. pregnancy or lactation; 11. subjects participated in other clinical trials in recent 3 months; 12. subject is considered as dementia, a serious mental disorder (depression or mania), and personality or behavioral disorders through cognitive and behavioral test; 13. cannot cooperate on the research; 14. severe brain atrophy, or existing brain injury such as cerebral infarction, cerebral vascular malformation or trauma; 15. severe systemic diseases; 16. severe dyskinesia or frequent "off" or "on" states 17. severe infectious diseases (eg hiv, hcv, hbv, syphilis positive) 18. not suitable to participate in this clinical trial assessed by other physicians
phototherapy for treatment of raynaud's phenomenon

Conditions: Raynaud Disease; Raynaud Phenomenon; Raynaud Syndrome

Summary: to determine if blue light therapy can improve the symptoms of raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

the purpose of this study is to test the efficacy of blue light phototherapy for the treatment of raynaud's phenomenon (rp) in human participants. the specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that rp participants experience. this will be measured through the use of a visual analog scale (vas) of both pain and numbness. this study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. together, the visual analog scale (vas) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced rp symptoms due to vasodilation of blood vessels.

Eligibility criteria:
inclusion criteria: - must have a current diagnosis by a physician of raynaud's phenomenon/syndrome exclusion criteria: * those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them. * inability of the subject to place their hands into the ptd portal because of physical size or discomfort. * inability of the subject to wear protective eyewear. * anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures. * females who are pregnant. * adults unable to consent for any reason not explicitly stated herein.
airvo device intervention for moderate to severe copd

Conditions: COPD; COPD Exacerbation

Summary: this is an open (non-blinded), single-arm, clinical trial to assess the efficacy of daily use of a high-flow nasal cannula (hfnc) device in patients with moderate to severe copd, in addition to standard care, in reducing the amount of copd exacerbations over a one-year period. once enrolled in the study, all subjects will be asked to undergo a baseline walking test to measure pulmonary function (6mwt), verify their personal and medical history (demographics), as well as fill in some questionnaires regarding their copd and its symptoms (sgrq-c, cat). all subjects will then receive their own airvo2 device, as well as training and instructions on how to use the device at home. subjects will use the myairvo2 device daily for the following 12 months. follow-up visits will occur five times over the 12-month study period and will be similar to the baseline visit. additional data will be collected by the study team for each subject from their electronic medical record during the 12-month study enrollment period. only information regarding copd-related medical and/or pharmacy costs, specifically to measure the amount of copd exacerbations experienced by each subject, will be reviewed and recorded.


Eligibility criteria:
inclusion criteria: * • moderate to severe copd * ≥2 inpatient or outpatient claims (er, or urgent care included) in the previous calendar year * ≥2 copd exacerbations in previous year * current established care within the reno/sparks area * residing in washoe county or carson city county * ability to travel to site * willing to use myairvo™2 for at least four hours per day but preferably ≥7 hours or overnight and be capable of handling the myairvo™2 device after instruction * prior pft data available prior to admission into project * understand and accept oral and written information in english * life expectancy greater than 1 year exclusion criteria: * • end-stage renal disease (esrd) * comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness, covid-19) * oxygen requirements greater than 6 l/min * bipap or cpap use in home * receiving hospice care * pcp/pi determines the patient is not a good candidate for project inclusion * lung ca * active smoker status

Keywords: airvo